Albumin-based pharmaceutical compositions have been developed as a drug delivery system for delivering a substantially water insoluble drugs such as taxane. See, for example, U.S. Pat. Nos. 5,916,596 A, 6,506,405 B1, 6,749,868 B1, 6,537,579 B1, 7,820,788 B2, and 7,923,536 B2. For example, nab-paclitaxel sold under the trademark ABRAXANE®, an albumin-stabilized nanoparticle formulation of paclitaxel, is a prescription drug approved to treat life-threatening cancers that affect hundreds of thousands of patients in the United States. Nab-paclitaxel sold under the trademark ABRAXANE® is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer (“NSCLC”), as well as metastatic adenocarcinoma of the pancreas. Additionally, ABI-009, an albumin-stabilized nanoparticle formulation of rapamycin, has been reported to exhibit evidence of response in a Phase I trial of patients with advanced nonhematologic malignancies. See Gonzalez-Angulo, A. M. et al. Clin. Cancer Res. 2013.
It is generally believed that albumin-based nanoparticles, such as those in ABI-009 and nab-paclitaxel sold under the trademark ABRAXANE®, when introduced into the blood stream, would dissolve into albumin-drug complexes. Such albumin-drug complexes utilize the natural properties of albumin to transport and deliver substantially water insoluble drugs to the site of disease, such as tumor sites. In addition, the albumin-based nanoparticle technology offers the ability to improve a drug's solubility without the need for toxic solvents in the administration process, thus potentially improving safety through the elimination of solvent-related side effects.
The disclosures of all publications, patents, patent applications, and published patent applications referred to herein are hereby incorporated herein by reference in their entireties.